BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER

    MDR report key: 6214145 · Received December 29, 2016

    Report

    Report Number
    9680001-2016-00104
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    November 16, 2016
    Report Date
    March 10, 2017
    Manufacturer
    VENUSA DE MEXICO S.A. DE C.V.
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENTS, DESCRIBE EVENT OR PROBLEM, EVALUATION CODES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THE LOG FILES FROM THE TACTISYS QUARTZ SYSTEM WERE RETURNED. THE RESULTS OF THE ANALYSIS PERFORMED ON THE LOG FILES CONCLUDED THAT THE TACTICATH CATHETER PERFORMED AS INTENDED. THE OPTICAL SIGNALS CONFORMED TO SPECIFICATIONS, THE RECORDED TEMPERATURES INDICATED COOLING DURING RF ABLATION, AND FORCE MEASUREMENTS WERE DISPLAYED THROUGHOUT THE PROCEDURE. FORCE MEASUREMENTS WERE RECORDED DURING ABLATION THAT EXCEEDED THE RECOMMENDED VALUES IN THE INSTRUCTIONS FOR USE (IFU); HOWEVER, DUE TO UNKNOWN PROCEDURAL CONDITIONS WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. THE CAUSE OF THE REPORTED FISTULA AND SUBSEQUENT DEATH REMAINS UNKNOWN. PER THE IFU, ATRIOESOPHAGEAL FISTULA IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT DEVELOPED AN ATRIOESOPHAGEAL FISTULA. THE ABLATION PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT LATER PRESENTED TO THE EMERGENCY DEPARTMENT WITH FEVER-LIKE SYMPTOMS. AN ATRIOESOPHAGEAL FISTULA, WHICH DID NOT CONNECT TO THE LEFT ATRIUM, WAS DIAGNOSED AND SURGICALLY REPAIRED. POST OPERATIVELY, IT WAS REVEALED THERE WAS CEREBROVASCULAR DAMAGE, POSSIBLY DUE TO AN AIR EMBOLISM DURING SURGERY. THE PATIENT REMAINS IN THE ITU AT THE TIME OF THIS REPORT. FURTHER INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 22JAN2017 THAT THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT DEVELOPED AN ATRIOESOPHAGEAL FISTULA. THE ABLATION PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THE PATIENT LATER PRESENTED TO THE EMERGENCY DEPARTMENT WITH FEVER-LIKE SYMPTOMS. AN ATRIOESOPHAGEAL FISTULA, WHICH DID NOT CONNECT TO THE LEFT ATRIUM, WAS DIAGNOSED BY A CT SCAN OF THE THORAX AND WAS SURGICALLY REPAIRED WITH AN ESOPHAGEAL STENT. POST OPERATIVELY, IT WAS REVEALED THERE WAS CEREBROVASCULAR DAMAGE, AND IT WAS CONFIRMED BY A CEREBRAL CT SCAN THAT AN AIR EMBOLI HAD TRAVELLED TO THE BRAIN. THE PATIENT WAS TRANSFERRED TO THE ITU AND THEN EXPIRED AT A LATER DATE. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864498 TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAE VENUSA DE MEXICO S.A. DE C.V. PN-004 065 5420389

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death| H| R